Impact of Court Cases on Summary of Product Characteristics Harmonisation

Abstract

This paper deals with the evolution of European Court of Justice (ECJ) case law. The ECJ had to decide in the Artedogan case whether the national authorities or the Commission should be able to modify marketing authorisation granted at the national level. The ECJ decided that in the situation where the marketing authorisation was of national origin, a modification could not be decided on by the European Commission on the basis of the then article 15a of directive 75/189 (today article 36 of directive 2001/83). The debate has now shifted, and the new issue is to decide who is authorised to force harmonisation of summaries of product characteristics (SmPC) and when this can be contested in front of the Court of First Instance. The three decisions pending in the Zocor, Lopid and Renitil cases, which concern SmPC harmonisation, will pave the way to finding out if the development of generic products can be impeded through the development or lack of SmPC harmonisation at the EU level.